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Disposable Trocars
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref 101Y.402Model Model A, Model B, Model C, Model D, Model E Ref 101Y.302-1000Ref 101Y.405Ref 101Y.621Ref 101Y.207Ref 101Y.B02Ref 101Y.G05DRef 800321Ref 101Y.J23Ref 101Y.316Ref 135Y.402-1000Ref 101Y.F23Ref 144Y.307-1000Ref 144Y.507Ref 101Y.207DRef 101Y.B07Ref 101Y.607Ref 101Y.308-1000Ref 800318Ref 800319Ref 101Y.550Ref 101Y.623Ref 101Y.F38Ref 101Y.304Ref 101Y.205Ref 101Y.305-1000Ref 101Y.216Ref 101Y.204Ref 101Y.B02DRef 101Y.G02Ref 101Y.H05Ref 101Y.C07Ref 101Y.202DRef 101Y.A05Ref 101Y.C02Ref 101Y.308Ref 101Y.E07Ref 144Y.302-1000Ref 800316Ref 101Y.J35Ref 101Y.302Ref 101Y.D07Ref 144Y.407Ref 101Y.552Ref 101Y.F53Ref 101Y.310Ref 101Y.H07Ref 144Y.405Ref 101Y.223Ref 101Y.622Ref 101Y.313
Identity
- Trade Name
- Disposable Trocars EUDAMED
- Device Name
- Disposable Trocars EUDAMED
- Model / Reference
- Model A, Model B, Model C, Model D, Model E EUDAMED101Y.402 EUDAMED101Y.302-1000 EUDAMED101Y.405 EUDAMED101Y.621 EUDAMED101Y.207 EUDAMED101Y.B02 EUDAMED101Y.G05D EUDAMED800321 EUDAMED101Y.J23 EUDAMED101Y.316 EUDAMED135Y.402-1000 EUDAMED101Y.F23 EUDAMED144Y.307-1000 EUDAMED144Y.507 EUDAMED101Y.207D EUDAMED101Y.B07 EUDAMED101Y.607 EUDAMED101Y.308-1000 EUDAMED800318 EUDAMED800319 EUDAMED101Y.550 EUDAMED101Y.623 EUDAMED101Y.F38 EUDAMED101Y.304 EUDAMED101Y.205 EUDAMED101Y.305-1000 EUDAMED101Y.216 EUDAMED101Y.204 EUDAMED101Y.B02D EUDAMED101Y.G02 EUDAMED101Y.H05 EUDAMED101Y.C07 EUDAMED101Y.202D EUDAMED101Y.A05 EUDAMED101Y.C02 EUDAMED101Y.308 EUDAMED101Y.E07 EUDAMED144Y.302-1000 EUDAMED800316 EUDAMED101Y.J35 EUDAMED101Y.302 EUDAMED101Y.D07 EUDAMED144Y.407 EUDAMED101Y.552 EUDAMED101Y.F53 EUDAMED101Y.310 EUDAMED101Y.H07 EUDAMED144Y.405 EUDAMED101Y.223 EUDAMED101Y.622 EUDAMED101Y.313 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06950465504145 EUDAMED06950465505999 EUDAMED06950465504152 EUDAMED06950465508877 EUDAMED06950465502998 EUDAMED06950465509447 EUDAMED06950465509485 EUDAMED06950465571338 EUDAMED06950465515721 EUDAMED06950465500222 EUDAMED06950465575510 EUDAMED06950465507757 EUDAMED06950465541218 EUDAMED06950465561131 EUDAMED06950465555093 EUDAMED06950465509461 EUDAMED06950465506699 EUDAMED06950465533268 EUDAMED06950465571307 EUDAMED06950465571314 EUDAMED06950465507603 EUDAMED06950465508891 EUDAMED06950465509294 EUDAMED06950465544844 EUDAMED06950465502981 EUDAMED06950465506019 EUDAMED06950465504053 EUDAMED06950465501960 EUDAMED06950465509423 EUDAMED06950465510184 EUDAMED06950465510238 EUDAMED06950465507153 EUDAMED06950465555079 EUDAMED06950465511563 EUDAMED06950465507139 EUDAMED06950465537839 EUDAMED06950465511709 EUDAMED06950465541195 EUDAMED06950465571284 EUDAMED06950465532827 EUDAMED06950465500024 EUDAMED06950465506972 EUDAMED06950465557622 EUDAMED06950465507641 EUDAMED06950465507764 EUDAMED06950465501953 EUDAMED06950465510245 EUDAMED06950465557615 EUDAMED06950465507337 EUDAMED06950465508884 EUDAMED06950465500079 EUDAMED
- Basic UDI-DI
- 69504655101YJN EUDAMED
- EMDN Code
- K01010101 TROCAR STANDARD, SINGLE-USE EUDAMEDK01010103 OPTICAL TROCAR, SINGLE-USE EUDAMEDK01010102 HASSON TROCAR, SINGLE-USE EUDAMEDK01010105 SPECIAL TROCAR, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMEDFrance EUDAMEDSweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Trocars by Hangzhou Kangji Medical Instrument Co. Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233263 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 69504655101YJN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hangzhou Kangji Medical Instrument Co. Ltd
- EUDAMED SRN
- CN-MF-000008708
- Authorised Representative
- Llins Service & Consulting GmbH DE-AR-000009077
Sources (52)
- EUDAMED cda5aecb-e3c6-4431-880d-71b3abbf3af8 61 fields · synced Oct 6, 2026
- EUDAMED ad26e619-6183-43b2-8786-619601e2c9b8 61 fields · synced May 18, 2026
- EUDAMED bfb06575-09fb-479b-8f34-b4949775ace7 61 fields · synced May 18, 2026
- EUDAMED e6071e41-7dc3-4332-a2e5-6b2b3d1d15d1 61 fields · synced May 18, 2026
- EUDAMED b5c62f95-39d9-4463-890d-d46867201ff6 61 fields · synced May 19, 2026
- EUDAMED 7c2df3b9-585d-4e09-b8d5-828dbef9406b 61 fields · synced Jun 14, 2026
- EUDAMED fa132b01-b624-42b9-8551-fc0b6023c57f 61 fields · synced Jun 18, 2026
- EUDAMED a2caedf6-27b5-47b2-a10f-36258c2f1ce0 61 fields · synced Jun 20, 2026
- EUDAMED cd25b865-7853-4c78-ae6a-741f28b549f7 61 fields · synced Jun 20, 2026
- EUDAMED 119af7bd-972c-46ae-a66a-22ff8bd3787e 61 fields · synced Jun 20, 2026
- EUDAMED 7f341148-c1f1-496c-a6b8-caf189ac0dfc 61 fields · synced Jun 20, 2026
- EUDAMED 39f39282-3fcf-4d75-9560-9d10cdbf7182 61 fields · synced Jun 20, 2026
- EUDAMED d928ccd2-5da1-485c-a3af-0d749ebcd250 61 fields · synced Jul 9, 2026
- EUDAMED 5b4c59c0-7a12-493e-87f5-14424cf7cd86 61 fields · synced Jul 9, 2026
- EUDAMED 9b8e87a7-41ff-41c0-9b42-db95c4d4e7d8 61 fields · synced Jul 9, 2026
- EUDAMED 20044d06-d87b-4032-b0cf-2052ec166871 61 fields · synced Jul 9, 2026
- EUDAMED 76f72c9f-a646-4850-9278-708048f3c169 61 fields · synced Jul 9, 2026
- EUDAMED b73b0cf7-08f6-47d4-b006-07a7cb6cc603 61 fields · synced Jul 9, 2026
- EUDAMED d230b81a-d4ea-4fdf-bbe7-cc23506a3b97 61 fields · synced Jul 9, 2026
- EUDAMED 3719ac58-fe34-4e6d-85e4-2c840fe8074f 61 fields · synced Jul 9, 2026
- EUDAMED 727f0802-1a18-4f69-b7ee-8199c59b6a66 61 fields · synced Jul 10, 2026
- EUDAMED 6a0c4271-46bf-431c-bf84-195aaab60270 61 fields · synced Jul 10, 2026
- EUDAMED 4030a6a7-484d-4ef1-9ce6-5e018a7f949b 61 fields · synced Jul 10, 2026
- EUDAMED 1a924efd-325f-42c1-9698-05e63ce78880 61 fields · synced Jul 10, 2026
- EUDAMED cc8b8c56-b3d4-4d03-8e14-83c17057f1be 61 fields · synced Jul 10, 2026
- EUDAMED 5cdbe41b-ebf8-4905-bc3e-a6f704f3d3ae 61 fields · synced Jul 10, 2026
- EUDAMED 9370a1f2-eea0-4293-8124-0d5621387951 61 fields · synced Jul 10, 2026
- EUDAMED d1ae0ce7-e4c6-4758-a6d7-daac923529c4 61 fields · synced Jul 10, 2026
- EUDAMED 1cbcb154-4a53-47ef-b4b0-73670a1349df 61 fields · synced Jul 11, 2026
- EUDAMED bd619ff9-a971-4af3-9926-f8df29b6cfd9 61 fields · synced Jul 12, 2026
- EUDAMED c2932842-3c1b-4dea-a6f0-dcf4493e3813 61 fields · synced Jul 12, 2026
- EUDAMED 38b495b4-6e0f-4a88-8e95-b197ce3238ba 61 fields · synced Jul 12, 2026
- EUDAMED 0e7926c8-e2a8-40e1-9a51-53733aca0539 61 fields · synced Jul 13, 2026
- EUDAMED c0c26fb7-c913-41ff-8f91-5375257a04d4 61 fields · synced Jul 14, 2026
- EUDAMED 4fa2c0aa-1132-4c49-b8b4-2979a59d90c9 61 fields · synced Jul 15, 2026
- EUDAMED c227b231-e16b-4862-8351-dbd3d1b55ed5 61 fields · synced Jul 16, 2026
- EUDAMED 91678af1-ec8d-44e5-ac3e-5ba2fd79e80d 61 fields · synced Jul 17, 2026
- EUDAMED 230d4e67-0da3-4bbc-a3d7-13ecfb012196 61 fields · synced Jul 17, 2026
- EUDAMED cc215c69-c446-4286-b83f-ccd7893fa606 61 fields · synced Jul 17, 2026
- EUDAMED 0e2cb342-8add-4727-a426-f0d9105d07fa 61 fields · synced Jul 18, 2026
- EUDAMED 7cc959d0-e05b-42a7-824b-738ae1b81c9b 61 fields · synced Jul 19, 2026
- EUDAMED 11c5a0ca-cf0b-4a5e-aba4-4e77b81871c7 61 fields · synced Jul 20, 2026
- EUDAMED 213379e9-1181-421c-8f2f-19f439bf3cd0 61 fields · synced Jul 20, 2026
- EUDAMED 010e4338-c285-4537-838a-a9d92c4fd585 61 fields · synced Jul 21, 2026
- EUDAMED 98809f26-21cc-4833-9953-2e89f8c93e2a 61 fields · synced Jul 21, 2026
- EUDAMED 63318030-55b1-4b55-903e-26778a1337c7 61 fields · synced Jul 22, 2026
- EUDAMED 149eebb5-2840-4079-a26e-d85c18c15770 61 fields · synced Jul 23, 2026
- EUDAMED 6ad590e0-2f0a-4f00-a1be-e4bbf5ff1caf 61 fields · synced Jul 24, 2026
- EUDAMED f01524c6-e52d-40f5-acad-91173f9484f9 61 fields · synced Jul 24, 2026
- EUDAMED 5d9090e3-0d19-423c-bdc4-ce3dccf108e7 61 fields · synced Jul 25, 2026
- EUDAMED bca1d9b4-3ed3-4293-82a8-73ea4e4c82c6 61 fields · synced Jul 25, 2026
- FDA 510(k) K233263 1 fields · synced May 18, 2026